The FDA has approved Emblaveo (Abbvie), an intravenously administered fixed-dose combination of the monobactam antibacterial drug aztreonam and the beta-lactamase inhibitor avibactam, for use with metronidazole to treat complicated intra-abdominal infections (cIAIs) in adults.
STANDARD TREATMENT — Complications of intra-abdominal infections such as cholecystitis and acute perforated appendicitis often include abscess formation and peritonitis. Infections are usually polymicrobial; typical pathogens include enteric gram-negative organisms (most commonly Escherichia coli, Klebsiella...
- A Treprostinil Inhaler (Yutrepia) for Pulmonary Hypertension
- Sebetralstat (Ekterly) for Treatment of Hereditary Angioedema Attacks
- In Brief: Label Changes for Menopausal Hormone Therapy Products
- In Brief: Removal of Suicidality Warning from GLP-1 Agonists for Weight Management
- Denileukin Diftitox (Lymphir) for Cutaneous T-Cell Lymphoma (online only)
- Sevabertinib (Hyrnuo) for NSCLC (online only)
ISSUE
The FDA has requested the removal of some boxed warnings from the labels of vaginal and systemic menopausal hormone therapy (MHT) products. The warnings were initially added in 2003 based on the results of two placebo-controlled Women's Health Initiative (WHI) trials evaluating the use of systemic hormones for primary prevention of coronary heart disease (CHD) in postmenopausal women 50-79 years old.1-3
THE WHI TRIALS — In the first WHI trial, postmenopausal women 50-79 years old with an intact uterus who took oral conjugated equine estrogens and medroxyprogesterone had an increased risk of invasive breast cancer, CHD, stroke, and pulmonary embolism after a mean follow-up of 5.2 years.2 In the second WHI trial, postmenopausal women 50-79 years old without a uterus who took conjugated equine estrogens alone (without a progestin) had an increased risk of stroke, but not of breast cancer or CHD, after a mean …